Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2023 — Predicate Candidate Screening
3,346 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
131 daysmedian FDA review time
329 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230438 | URIS Smart Path Implant System & Prosthetic | Truabutment, Inc. | 2023-12-29 | 311 | 0 |
| K233790 | ACL TOP 970 CL | Instrumentation Laboratory | 2023-12-29 | 31 | 0 |
| K223714 | UniFit Dental Implant System | Adin Dental Implant Systems , Ltd. | 2023-12-29 | 382 | 0 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | 2023-12-29 | 88 | 0 |
| K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | 2023-12-29 | 267 | 0 |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for | Alcon Laboratories, Inc. | 2023-12-29 | 24 | 1 |
| K232688 | NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. | 2023-12-29 | 119 | 0 |
| K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy | Eco Medi Glove Sdn. Bhd. | 2023-12-28 | 84 | 0 |
| K230006 | Ankyras | Mentice Spain S.L. | 2023-12-28 | 359 | 0 |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trad | De Götzen S.R.L. | 2023-12-28 | 259 | 0 |
| K230985 | Planmeca Viso | Planmeca Oy | 2023-12-28 | 266 | 0 |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | 2023-12-28 | 265 | 0 |
| K230891 | SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implan | Healthium Medtech Limited | 2023-12-28 | 272 | 0 |
| K231914 | Nurochek-II System | Headsafe Mfg Pty, Ltd. | 2023-12-27 | 181 | 0 |
| K232518 | EndoSound Vision System; EVS | Endosound, Inc. | 2023-12-27 | 131 | 0 |
| K232756 | Colibrí | Copan Wasp Srl | 2023-12-27 | 110 | 0 |
| K233858 | TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences | 2023-12-27 | 22 | 0 |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023-12-27 | 254 | 0 |
| K233659 | Suture Wing | Osteonic Co., Ltd. | 2023-12-26 | 41 | 0 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 | 97 | 0 |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (32010 | Nuwellis, Inc. | 2023-12-26 | 55 | 0 |
| K233300 | POWEReam 1/4 Drive | Stryker Instruments | 2023-12-26 | 88 | 0 |
| K231130 | TumorSight Viz | SimBioSys, Inc. | 2023-12-26 | 250 | 0 |
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, | Alicn Medical Shenzhen, Inc. | 2023-12-22 | 140 | 0 |
| K230439 | WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023-12-22 | 304 | 0 |
| K233734 | Interson USB Ultrasound System | Interson Corporation | 2023-12-22 | 30 | 0 |
| K231794 | Elegant™ Advanced CompHort | Viramal Limited | 2023-12-22 | 185 | 0 |
| K233205 | Distal Access Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2023-12-22 | 85 | 0 |
| K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. | 2023-12-22 | 108 | 0 |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 | 88 | 0 |
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Colle | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023-12-22 | 95 | 0 |
| K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | 2023-12-22 | 86 | 0 |
| K233304 | Omnimax S3, Omnimax S4 | Sharplight Technologies, Ltd. | 2023-12-22 | 84 | 0 |
| K232789 | VIO System (V-1000) | Enspectra Health, Inc. | 2023-12-22 | 102 | 0 |
| K232479 | ART-Plan | Therapanacea | 2023-12-22 | 128 | 0 |
| K230267 | NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. | 2023-12-22 | 325 | 0 |
| K231086 | CPM System | Analog Devices, Inc. | 2023-12-22 | 249 | 0 |
| K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | 2023-12-22 | 123 | 0 |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | 2023-12-22 | 30 | 0 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023-12-22 | 373 | 0 |
| DEN230020 | BioTraceIO Lite | Techsomed Medical Technologies , Ltd. | 2023-12-22 | 267 | 0 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023-12-22 | 88 | 0 |
| K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023-12-22 | 87 | 0 |
| K234043 | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | 2023-12-22 | 1 | 0 |
| K231805 | qXR-LN | Qure.Ai Technologies | 2023-12-22 | 185 | 0 |
| K232293 | kallisio stentra™ oral stent | Kallisio, Inc. | 2023-12-22 | 143 | 0 |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | 2023-12-22 | 84 | 0 |
| K233104 | SofWave System | Sofwave Medical, Ltd. | 2023-12-22 | 87 | 0 |
| K232300 | ElastiMed SACS | Elastimed , Ltd. | 2023-12-22 | 143 | 0 |
| K233465 | RadiForce MX317W | Eizo Corporation | 2023-12-21 | 58 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda